Dataset Information

Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting.

ABSTRACT:

Objective

Mass-media campaigns have been known to modify the outcome of low back pain (LBP). We assessed the impact on outcome of standardized written information on LBP given to patients with acute LBP.

Methods

Design

A 3-month pragmatic, multicenter controlled trial with geographic stratification.

Setting

Primary care practice in France.

Participants

2752 patients with acute LBP.

Intervention

An advice book on LBP (the "back book").

Main outcome measures

The main outcome measure was persistence of LBP three months after baseline evaluation.

Results

2337 (85%) patients were assessed at follow-up and 12.4% of participants reported persistent LBP. The absolute risk reduction of reporting persistent back pain in the intervention group was 3.6% lower than in the control group (10.5% vs. 14.1%; 95% confidence interval [-6.3% ; -1.0%]; p value adjusted for cluster effect = 0.01). Patients in the intervention group were more satisfied than those in the control group with the information they received about physical activities, when to consult their physician, and how to prevent a new episode of LBP. However, the number of patients who had taken sick leave was similar, as was the mean sick-leave duration, in both arms, and, among patients with persistent pain at follow-up, the intervention and control groups did not differ in disability or fear-avoidance beliefs.

Conclusions

The level of improvement of an information booklet is modest, but the cost and complexity of the intervention is minimal. Therefore, the implications and generalizability of this intervention are substantial.

Trial registration

ClinicalTrials.gov NCT00343057.

SUBMITTER: Coudeyre E

PROVIDER: S-EPMC1939729 | biostudies-literature | 2007 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting.

Coudeyre Emmanuel E Tubach Florence F Rannou François F Baron Gabriel G Coriat Fernand F Brin Sylvie S Revel Michel M Poiraudeau Serge S

PloS one 20070808 8

<h4>Objective</h4>Mass-media campaigns have been known to modify the outcome of low back pain (LBP). We assessed the impact on outcome of standardized written information on LBP given to patients with acute LBP.<h4>Methods</h4><h4>Design</h4>A 3-month pragmatic, multicenter controlled trial with geographic stratification.<h4>Setting</h4>Primary care practice in France.<h4>Participants</h4>2752 patients with acute LBP.<h4>Intervention</h4>An advice book on LBP (the "back book").<h4>Main outcome m ...[more]

PMID: 17684553

Similar Datasets

Project description:BackgroundImaging is overused in the management of low back pain, resulting in overdiagnosis, increased healthcare utilisation, and increased costs. Few effective interventions to decrease inappropriate use have been developed and have typically not been developed using behaviour change theory. An intervention to reduce non-indicated imaging for low back pain was developed using behavioural change theory, incorporating a novel low back pain management booklet to facilitate patient education and reassurance. The aim of this study was to assess the adoption and feasibility of use of the developed intervention within clinical practice and to determine appropriate implementation strategies to address identified barriers to use.MethodsFourteen general medical practitioners were recruited and trained to use the booklet with low back pain patients over a minimum 5-month period. Quantitative data on use of the booklet were collected and analysed descriptively. Qualitative data on use of the booklet and training session were collected in general medical practitioner interviews and thematically analysed. Barriers to use were identified and mapped to suitable implementation strategies using the Behaviour Change Wheel.ResultsPractitioners used the booklet with 73 patients. The booklet was used with 63% of patients presenting with low back pain. Facilitators for using the booklet included patient's requesting imaging and lower practitioner confidence in managing low back pain. Barriers included accessible storage and remembering to use the booklet. Implementation strategies were identified to increase adoption and feasibility of use, including development of a digital version of the booklet.ConclusionsGeneral medical practitioners reported that the low back pain management booklet and training were useful for clinical practice, particularly with patients requesting imaging. Barriers to use were identified and implementation strategies to address these barriers will be incorporated into future effectiveness studies. This study forms one of a series of studies to thoroughly develop and test an intervention to reduce non-indicated imaging for low back pain; a successful intervention would decrease healthcare costs and improve patient management.

Project description:BackgroundInappropriate imaging and low-value care for low back pain (LBP) are common. A new patient-education booklet was created to overcome identified barriers to the delivery of recommended care, including the use of inappropriate imaging. Our aim was to assess the effectiveness of this booklet as part of primary care for LBP patients in comparison to usual care.MethodsA cluster-randomized trial was performed. The intervention involved providing practitioners with the new patient-education booklet and a 30-min training session on its use. The booklet was provided during the clinical consult to all consenting LBP patients in the intervention group. Primary outcomes were the proportion of patients presenting with LBP who underwent imaging examinations during the first three months of follow-up and PROMIS PF-20 (Patient-Reported Outcomes Measurement Information System, 20-item physical functioning short form) change between baseline and three-month follow-up. Secondary outcomes, including sick leave and imaging examinations at 12 months, were investigated. Logistic regression using GEE-estimation was used for dichotomous outcomes, Poisson regression using GEE-estimation for count outcomes, and linear mixed models for continuous outcomes.ResultsUsing the patient education booklet appeared to substantially reduce the proportion of LBP patients who underwent an imaging examination at three months, but the result was not statistically significant (OR 0.57, 95% confidence interval (Cl) 0.27 to 1.22). At 12 months, the effect was slightly larger and statistically significant (OR 0.50, 95%Cl 0.30 to 0.83, p = 0.008). No difference was observed in the PROMIS PF-20 T-score change between baseline and 3 months or 12 months (p = 0.365 and p = 0.923, respectively). The number of sick leave days in the intervention group was less than that in the control group at 3 months (RR 0.47, 95%Cl 0.26 to 0.83, p = 0.010) and at 12 months (RR 0.36, 95%Cl 0.18 to 0.72, p = 0.004).ConclusionsThe booklet appeared to be effective in reducing the proportion of LBP patients who underwent imaging examinations over 12 months. The intervention had no discernible effect on the PROMIS PF20 T-score change. The number of sick leave days was substantially lower in the intervention group.Trial registrationISRCTN, ISRCTN14389368 , Registered 4 April 2019-Retrospectively registered.

Project description:The general population has a pessimistic view of low back pain (LBP), and evidence-based information has been used to positively influence LBP beliefs in previously reported mass media studies. However, there is a lack of randomized trials investigating whether LBP beliefs can be modified in primary prevention settings. This cluster randomized clinical trial investigated the effect of an evidence-based psychosocial educational program (PSEP) on LBP beliefs for soldiers completing military training. A military setting was selected for this clinical trial, because LBP is a common cause of soldier disability. Companies of soldiers (n = 3,792) were recruited, and cluster randomized to receive a PSEP or no education (control group, CG). The PSEP consisted of an interactive seminar, and soldiers were issued the Back Book for reference material. The primary outcome measure was the back beliefs questionnaire (BBQ), which assesses inevitable consequences of and ability to cope with LBP. The BBQ was administered before randomization and 12 weeks later. A linear mixed model was fitted for the BBQ at the 12-week follow-up, and a generalized linear mixed model was fitted for the dichotomous outcomes on BBQ change of greater than two points. Sensitivity analyses were performed to account for drop out. BBQ scores (potential range: 9-45) improved significantly from baseline of 25.6 +/- 5.7 (mean +/- SD) to 26.9 +/- 6.2 for those receiving the PSEP, while there was a significant decline from 26.1 +/- 5.7 to 25.6 +/- 6.0 for those in the CG. The adjusted mean BBQ score at follow-up for those receiving the PSEP was 1.49 points higher than those in the CG (P < 0.0001). The adjusted odds ratio of BBQ improvement of greater than two points for those receiving the PSEP was 1.51 (95% CI = 1.22-1.86) times that of those in the CG. BBQ improvement was also mildly associated with race and college education. Sensitivity analyses suggested minimal influence of drop out. In conclusion, soldiers that received the PSEP had an improvement in their beliefs related to the inevitable consequences of and ability to cope with LBP. This is the first randomized trial to show positive influence on LBP beliefs in a primary prevention setting, and these findings have potentially important public health implications for prevention of LBP.

Project description:BackgroundA previous study has suggested that it is uncommon for patients with chronic bothersome low back pain (LBP), who consult the secondary health care sector, to report at least four consecutive weeks without such bothersome pain in 1 year. It is not yet known, however, how many days of the week they experience pain throughout the year.MethodThe current study analyzed data collected in two randomized clinical studies conducted in 2007-9 on patients with back pain (Study 1 and 2). Study participants were patients with LBP for more than 2 months, one group with MRI-defined Modic changes (Study 1) and the other without any pathological explanation for the pain (Study 2). In both studies, participants were followed over 1 year with weekly automated text messages (SMS-Track). Each week they reported the number of days they had experienced bothersome LBP (0-7 days). The number of weeks with 7 days of bothersome LBP was calculated for both study groups. As baseline and outcome characteristics were similar between the intervention and control groups in each study, the data from treatment and control groups in each study were analyzed together, regardless of treatment allocation and the results compared between the two study samples.ResultsThe proportion of patients reporting bothersome LBP all days of the week ranged from 0 to 100 %, with the findings arranged in a U-shaped curve. The pain frequency patterns were remarkably similar for the two study samples. At one extreme, 31 % of participants reported 0-10 % of weeks with daily LBP. At the other extreme, 25 % of participants reported 91-100 % of weeks with daily LBP. The distribution between these values was also very similar for the two groups.ConclusionThis study revealed there to be considerable variation in weekly persistence of symptoms during 1 year in patients from the secondary care sector with chronic LBP. The results range from bothersome pain each day of the week, every week of the year, to no weeks at all with 7 days of pain. Interestingly, this pattern is near-identical in the two study samples; those with non-specific LBP and those with LBP and Modic changes. This heterogeneic pain profile in patients with chronic LBP deserves to be further investigated.

Dataset Information

Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting.

Objective

Methods

Design

Setting

Participants

Intervention

Main outcome measures

Results

Conclusions

Trial registration

Publications

Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets